At a glance
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Phase 4 Study of Effects of Montelukast Treatment on Allergic Inflammation in Children With and Without Food Allergy, Single Centered, Randomised, Double Blind, Placebo Controlled Parallel Group Cross-over Study
In Brief
A Phase 4 clinical trial evaluating Montelukast for Bronchial Asthma and 2 related conditions. Completed, enrolled 113 participants across 1 site.
Detailed Summary
* To search the effects of montelukast on the airway inflammation including FEV1%, FEV1%/FVC, the provocholine® (methacoline chloride powder for inhalation) challenge tests, the leukotriene levels in the exhaled breath condensate in asthmatic children with and without food allergy aged 6-18 years old. * To define the patient groups with good response to montelukast and to define the parameters which predict the good response.
Study Details
Timeline
Interventions
Placebo and montelukast (5 mg for 6-14 years of age and 10 mg for 14-18 years of age once a day) will be given following one another in 4 weeks periods including a 2 weeks wash-out period in between in a cross over design.